Amgen Clinical Systems Manager in Thousand Oaks, California
Our eCOA Team:
Amgen eCOA Technical Specialists work with internal stakeholders and eCOA vendors to support the eCOA system delivery, maintenance and provide subject matter expertise for projects related to eCOA deployments.
eCOA Technical Specialist role overview:
The electronic Clinical Outcomes Assessments (eCOA) Technical Specialist will work with a cross functional team of Clinical representatives to support the design, implementation and maintenance of outsourced eCOA systems to support clinical trials. The individual within this role will provide technical oversight to ensure that the study specific eCOA systems adheres to the study protocol, industry regulations / best practices as well as company policies, procedures and guidelines.
Accountable for quality delivery and competencies within the eCOA service area
Oversee study level system requirements meetings with eCOA vendors and internal stakeholders
Assist in the design and development of study specific technical documents
Support the internal team in managing project related timelines and associated activities
Partner with data management (DM) to define the requirements for data transfers
Work with external resources to manage the creation and execution of user acceptance tests
Identify and track study-related technical issues to resolution
Provide a supportive framework for continuous process and quality improvements
Qualifications and required experience:
Master's Degree and
Proven experience and skills needed:
Bachelor’s Degree in life science, computer science, engineering, business or related discipline
Experience in clinical development
Experience implementing clinical systems, such as CTMS, EDC, IVRS, ePRO or other related technology in the pharmaceutical/biotechnology industry
Knowledgeable in Good Clinical Practices, and FDA regulations necessary
Project management and technical expertise, attention to detail, and excellent documentation and communication skills
Previous vendor management experience
Excellent time management and organization skills
Have sound problem resolution, judgment, and decision-making abilities
Be able to work well in a team-based environment with minimal supervision
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.